跳至主要内容
临床试验/NCT05944822
NCT05944822进行中(未招募)不适用

Study of Pro-inflammatory Cytokines in Case of Essure® Contraceptive Implants

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
1
主要终点
cytokine IL10 in peritoneal fluid

研究概览

简要总结

It is estimated that 750,000 women (including 200,000 French) have benefited from permanent sterilization by ESSURE® contraceptive implant. The observation in some of these patients of gynecological and extra-gynecological symptoms leads to the surgical removal of these implants.

The pathophysiological mechanism(s) is (are) not yet determined. Several pathophysiological hypotheses have been proposed, in particular the inflammatory hypothesis. The investigators propose to study markers of inflammation (pro-inflammatory cytokines) in peritoneal fluid and blood. Cytokines are involved in the physiopathology of autoimmune diseases, infectious pathologies, or even cancer; they are used in everyday practice and can constitute a therapeutic target.

Based on the literature which finds a high concentration of cytokines in cases of endometriosis, and a low concentration in healthy control patients, the investigators want to assess inflammation in patients with Essure® implants.

The demonstration of one or more specifically increased cytokines in the Essure® group could validate the inflammatory hypothesis and lead to the implementation of specific treatments and relevant markers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women over 18
  • intervention between January 2021 and November 2022
  • person having expressed his non-opposition
  • Essure group : patient who underwent removal of the Essure® contraceptive implant
  • Control with no endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis
  • Control with endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis

排除标准

  • inability to understand the information given
  • person deprived of liberty
  • person under guardianship

结局指标

主要结局

cytokine IL10 in peritoneal fluid

时间窗: through study completion, an average of 4 months

Level of cytokine IL10 in peritoneal fluid

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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